A Prospective Study of Postpartum Depression in Women With Major Depression
NCT ID: NCT01328613
Last Updated: 2019-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
85 participants
OBSERVATIONAL
2007-11-09
2014-09-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
\- Postpartum depression (PPD) is a serious syndrome that resembles a major depressive episode and occurs in 10% to 20% of all mothers in the year following delivery. Women with histories of major depressive disorder (MDD) are at an increased risk for PPD and recurrent PPD with subsequent pregnancies. One possible genetic vulnerability to depression and PPD in particular is the BDNF gene. BDNF is a protein that affects the growth and development of brain cells, including those that help to regulate mood. BDNF levels have been shown to be significantly lower in individuals with depression, including women. Researchers are interested in studying BDNF levels and hormones such as estrogen in pregnant women who have MDD and are at risk for developing PPD.
Objectives:
\- To study connections between the BDNF protein and hormonal levels in pregnant women who are at risk for developing postpartum depression.
Eligibility:
\- Women who are currently pregnant and have a history of major depressive disorder, and either are taking a selective serotonin reuptake inhibitor (SSRI) or are not taking an antidepressant.
Design:
* This study involves six visits over the course of 12 months, during the first, second, and third trimesters (if possible) as well as 1 week, 1 month, and 3 months postpartum. Women will be allowed to participate at any point during pregnancy, but researchers are most interested in recruiting women who are in the first trimester.
* Participants will be screened with a physical examination and medical history, blood samples, and questionnaires about their history of depressive episodes.
* At each visit, participants will complete a number of questionnaires on depression symptoms, such as sleep disturbance and stress levels. Participants will also provide blood samples for hormone and other testing.
* Participants who become depressed during the study will be referred to a treating psychiatrist or other professional for appropriate care and treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Screening Evaluation for Women With Postpartum Depression
NCT00056901
Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression
NCT01648816
Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers
NCT03638687
A Study of Pregnant and Postpartum Women With and Without Mood Disorders
NCT03615794
Postpartum Depression
NCT05595512
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All subjects in this study will be enrolled, evaluated and serum samples collected by Dr. Payne and her staff at Johns Hopkins University School of Medicine under Dr. Payne s already Johns Hopkins approved IRB protocol NA\_0008149.
NIA Role:
Coded serum samples will then be sent to Dr. Mattson at the NIA facility. Data obtained in the analysis of serum samples will be sent to Dr. Payne and maintained in her database, and analyzed to elucidate relations between levels of serum markers and clinical and genetic data acquired by Dr. Payne.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
In order to minimize heterogeneity in the sample, all women must be currently taking a serotonin reuptake inhibitor (SSRI) antidepressant medication or not taking antidepressants.
We will attempt to recruit approximately 50% in each category (SSRI versus no medications). If a woman becomes depressed during the study she will be referred to her treating psychiatrist or given appropriate clinical care. We will continue to follow women for the specified time course even if she placed on an (any) antidepressant medication during the course of the study.
Exclusion Criteria
Current active suicidal ideation or medical instability
Active substance abuse or dependence during the last 90 days.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark P Mattson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute on Aging (NIA)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Campbell SB, Cohn JF. Prevalence and correlates of postpartum depression in first-time mothers. J Abnorm Psychol. 1991 Nov;100(4):594-9. doi: 10.1037//0021-843x.100.4.594.
Hunt N, Silverstone T. Does puerperal illness distinguish a subgroup of bipolar patients? J Affect Disord. 1995 May 17;34(2):101-7. doi: 10.1016/0165-0327(95)00006-9.
Kumar R, Robson KM. A prospective study of emotional disorders in childbearing women. Br J Psychiatry. 1984 Jan;144:35-47. doi: 10.1192/bjp.144.1.35.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
08-AG-N320
Identifier Type: -
Identifier Source: secondary_id
999908320
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.